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UCB Pharma Limited
208 Bath Road, Slough, Berkshire, SL1 3WE
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: Medicalinformationuk@ucb.com
Customer Care direct line: +44 (0) 1773 510123

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 02/07/2010
SPC Isoket 1 mg/ml concentrate for solution for injection or infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 02/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8: updated in line with CCDS and MedDRA coding convention
Section 4.9: updated in lin ewith CCDS recommendations
Section 10: updated to reflect approval date of the above changes
Updated on 03/06/2010 and displayed until 02/07/2010
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3: pre-clinical informaiton added.
Section 10: updated to reflect approval of the above change.
Updated on 12/05/2010 and displayed until 03/06/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3, 4.4 & 4.5: updated in line with CCDS

Section 4.7: included warning for use during driving or operating machinery

Section 10: updated to reflect approval of above changes.
Updated on 26/01/2010 and displayed until 12/05/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5: Adding neuroleptics, tricyclics and ergotamine to interactions and clarifying the phosphodiesterase-5 inhibitors wording.

Section 4.7: Addition of the standard drive or operate machinery warning.
Updated on 04/01/2010 and displayed until 26/01/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: strength expressed in mg/ml and pharmaceutical form updated
Section 2: updated in line with SmPC guideline
Section 3: Updated to reflect EU Standard Terms and SmPC guideline
Section 4.2: Cross reference to section 6.6 included.
Section 6.1: Updated details of existing exipients in line with SmPC guideline
Section 6.2: Moved details concerning use of product to section to section 6.6 and included standard wording that the product should not be mixed with other medicinal products except thos e mentioned in 6.6.
Section 6.6: Now includes details moved from section 6.2
Section 10: Updated according to reflect variation approval date.
Updated on 10/05/2007 and displayed until 04/01/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Full product name added in line with EU requirements
Section 2 - Full Qualitative and Quantitative composition added in line with EU requirements
Section 3 - Updated pharmaceutical form in line with EU requirements
Section 6.5 - Updated Nature and Contents of container
Section 10 - Updated date of revision
Updated on 27/09/2006 and displayed until 10/05/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (MA Holder) - New address added: SCHWARZ PHARMA Limited, 5 Hercules Way, Leavesden Park, Watford, WD25 7GS, United Kingdom.
 
Section 10 (Date of revision of text) - New date added: July 2006
Updated on 02/06/2005 and displayed until 27/09/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 05/02/2003 and displayed until 02/06/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 27/09/2002 and displayed until 05/02/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 31/07/2002 and displayed until 27/09/2002
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/08/2001 and displayed until 31/07/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 03/08/2001 and displayed until 21/08/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 20/07/2000 and displayed until 03/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 18/01/2000 and displayed until 20/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 18/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  isosorbide dinitrate